NASH Trials

Clinical Trials in Nonalcoholic Steatohepatitis (NASH)

Phase 2a

Assesses preliminary effectiveness and safety of drug

Inclusion criteria usually include the following:

  • Raised ALT or AST
  • Hepatic steatosis *(Fibroscan CAP measurement of fat >300)
  • Fibroscan consistent with F2-3 fibrosis
  • *MRI-PDFF >8-10%

*done during screening at Trial site

Duration 12-24 weeks

Efficacy assessed by:

  • Change in ALT or AST
  • Change in MRI-PDFF

Phase 2b/3

Inclusion criteria:

  • Liver biopsy
    • Within 6 months of randomisation
    • F2-3 with NAS ³4
  • +/- MetS criteria

Duration

  • Phase 2b 12-18 months
  • Phase 3 4-6 years

Efficacy assessed by

  • Repeat biopsy at 12-18 months – aiming for Improvement in Fibrosis by ³1 and/or inflammation
  • Phase 3 includes longer term –additional biopsy at 48 months

Endpoints:

  • Progression to cirrhosis
  • Decompensation event, HCC, liver transplantation or death

Trials currently recruiting

Enyo

Phase 2a Trial

– https://clinicaltrials.gov/ct2/show/NCT03812029

Need elevated ALT, raised liver stiffness (consistent with F2-3 firbsosi) and liver fat content (MRI-PDFF) at least 10%

Madrigal

Phase 3/4 Trial

https://clinicaltrials.gov/ct2/show/NCT04197479?term=maestro&cond=nash&draw=2&rank=1